Clinical Trial

Lead Evaluation for Defibrillation and Reliability Post Approval Study

Study acronym: LEADR PAS
Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release. The LEADR PAS is conducted within Medtronic's Product Surveillance Registry Platform (NCT01524276).
Protocol Amendment History 2 changes
notable Trial sites expanded: 49 -> 73 locations 2026-08-04
notable Trial sites expanded: 29 -> 49 locations 2026-04-28
Trial Details
NCT Number NCT07005232
Lead Sponsor Medtronic
Conditions Tachyarrhythmia
Enrollment 2,000 participants
Start Date 2026-01-07
Primary Completion 2032-09 (estimated)
Study Completion 2032-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-03